- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440528
Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer
September 17, 2023 updated by: Nashwa Radwan, Egyptian Atomic Energy Authority
To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.
Study Overview
Status
Completed
Conditions
Detailed Description
Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 29
- Amniotic tissue lab
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study is based on randomized selection of 3 types of ulcer ( diabetic foot ulcer, post operative ulcer and ultrasonic ulcer)
Description
Inclusion Criteria:
- patients have unhealing ulcer
Exclusion Criteria:
- must stop other line of treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Size of ulcer
Time Frame: 2 week
|
REGE pro decreased size of ulcer after second treatment
|
2 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of pain
Time Frame: 1 week
|
Patients response revealed reduction of pain at the time of application.
One week post application, a questionnaire were collected from patients; about 95% of them ensured that pain was controlled.
|
1 week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete curring
Time Frame: 4 to 10 weeks
|
REGE pro healed ulcer after 4 to 10 weeks.
The improvement of ulcer was observed by photographs taken before and each week post application.
|
4 to 10 weeks
|
Freedom from scarring
Time Frame: 10 weeks
|
It was observed that the using of REGE pro prevent any scar formation in all applied patients.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Nashwa K Radwan, PhD, NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
December 30, 2017
First Submitted That Met QC Criteria
February 19, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 17, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29112017NCRRT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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